- Contract opportunity within a global medical device organisation
- Work with cutting edge technologies
- Exposure to a broad range of regulatory activities across the product lifecycle
- Collaborate with experienced global Regulatory Affairs and cross-functional teams

About the company

Join a global medical technology organisation focused on developing innovative products that support improved patient outcomes.

Operating across highly regulated international markets, the business has a strong focus on quality, compliance and continuous improvement, with established teams across Regulatory Affairs, Quality, Engineering and other key functions.

About the opportunity

An exciting contract opportunity is available for a Regulatory Affairs professional to join a global medical device organisation. Working as part of a global Regulatory Affairs function, you will support a broad range of regulatory activities across the product lifecycle. This is a diverse role covering regulatory submissions, technical documentation, product and process change assessments, post-market activities, CAPA, labelling and regulatory compliance.

You will work closely with cross-functional teams and provide regulatory guidance to ensure products continue to meet applicable regulatory requirements.

Duties

- Support regulatory strategies and prepare submissions and technical documentation for product approvals
- Conduct regulatory impact assessments for product and process changes
- Review QMS change orders, design change orders and non-conformance reports
- Assess product changes to determine potential regulatory impact on product safety and effectiveness




- Review product labelling and marketing materials to ensure regulatory compliance and appropriate product claims
- Support regulatory‑related CAPAs, including root cause investigations, implementation of corrective actions and effectiveness checks
- Work with corporate teams to support field actions and product recalls
- Support post‑market surveillance activities
- Partner with cross‑functional teams to ensure regulatory and quality requirements are considered across projects and initiatives
- Ensure local Regulatory Affairs activities align with global policies and standards

Skills and Experience

- Bachelor’s degree in Science, Biomedical Engineering, Regulatory Affairs or a related discipline
- Medical device Regulatory Affairs experience highly regarded
- Experience working with software‑based medical device products highly desirable
- Understanding of TGA requirements, EU MDR and international medical device regulations
- Experience supporting regulatory submissions and technical documentation
- Strong analytical skills with excellent attention to detail
- Ability to assess regulatory impact associated with product and process changes
- Strong written and verbal communication skills
- Confident working across multiple stakeholders and cross‑functional teams
- Self‑motivated with the ability to manage competing priorities and deadlines

Culture

Join a collaborative and globally connected environment where Regulatory Affairs works closely with Quality, Engineering and broader business teams.

The organisation values initiative, sound judgement, professionalism and continuous improvement, with a strong focus on delivering safe and compliant medical devices.

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📌 Regulatory Affairs Associate (City of Sydney)
🏢 Healthcare Professionals Group
📍 City of Sydney